This Day On The Street
Continue to site
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

BioSante Punished After Intrinsa Vote

"The FDA clearly wants to see more safety data, but the good news for us is that we are still designing our phase III trials, so we can include the recommendations of the [Intrinsa] panel into our protocol," says Simes. He adds that any delay in the start of the LibiGel phase III studies will be measured in months, not years.

Could this be wishful thinking? Certainly. One of the panel members reviewing Intrinsa's safety, Dr. Steven Nissen, a cardiologist at Cleveland Clinic, suggested that adequate safety data would only come after studying Intrinsa's use in thousands of women, maybe tens of thousands of women. These are hugely expensive and time-consuming studies typically required for drugs like cholesterol-lowering statins.

The FDA has been stung by sharp criticism that it is too lax on drug safety, especially following Merck's (MRK) withdrawal of Vioxx from the market. So, it's not out of the realm of possibility to see the agency take a hard line with Proctor & Gamble about Intrinsa safety data.

Bottom line: Until Proctor & Gamble meets with the FDA to hammer out the exact safety requirements for Intrinsa, BioSante's plans for LibiGel will also be on hold. And even if BioSante manages to get its phase III studies started relatively soon, the added burden of collecting more safety data could stretch out completion of the trials for many more months, if not years.

Simes says he's hopeful that BioSante will be able to piggyback on any safety data collected by Proctor & Gamble -- and make BioSante's task less onerous -- because testosterone, whether it enters the bloodstream via a patch (with Intrinsa) or through a gel application (with LibiGel), will have the same effect on a woman's body.

To date, BioSante has been determined to develop LibiGel on its own, in order to maximize the potential for the product to its shareholders. But Thursday's setback could force the company to raise more money to pay for larger, lengthier studies, or partner LibiGel with a larger company at less ideal terms.

It needs to be noted that BioSante is not a one-trick pony. The company does have other hormone therapy products in development, including an estrogen gel for women. Bio-E-Gel is wrapping up a pivotal phase III study and should be filed with the FDA in the middle of 2005. Unlike LibiGel, Bio-E-Gel shouldn't run into unexpected regulatory delays because similar products are already on the market.

Please note that due to factors including low market capitalization and/or insufficient public float, we consider BioSante Pharmaceuticals to be a small-cap stock. You should be aware that such stocks are subject to more risk than stocks of larger companies, including greater volatility, lower liquidity and less publicly available information, and that postings such as this one can have an effect on their stock prices.
Adam Feuerstein writes regularly for In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in He also doesn't invest in hedge funds or other private investment partnerships. He invites you to send your feedback to .
2 of 2

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

David Peltier identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Real Money

More than 30 investing pros with skin in the game give you actionable insight and investment ideas.

Product Features:
  • Access to Jim Cramer's daily blog
  • Intraday commentary and news
  • Real-time trading forums
Only $49.95
14-Days Free
14-Days Free
PG $81.20 0.00%
AAPL $94.02 0.00%
FB $104.07 0.00%
GOOG $683.57 0.00%
TSLA $162.60 0.00%


Chart of I:DJI
DOW 16,204.97 -211.61 -1.29%
S&P 500 1,880.05 -35.40 -1.85%
NASDAQ 4,363.1440 -146.4150 -3.25%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs